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FDA 510(k)

CRANIAL REMOLDING ORTHOSIS

K-Number: K111247 · 2011-08-15

ApplicantOrthotic Care Services, Llp
Decision Date2011-08-15
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANIAL REMOLDING ORTHOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Orthotic Care Services, Llp. It received FDA 510(k) clearance on 2011-08-15 under 510(k) number K111247. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRANIAL REMOLDING ORTHOSIS?

CRANIAL REMOLDING ORTHOSIS is a medical device that received FDA 510(k) clearance on 2011-08-15. The listed applicant is Orthotic Care Services, Llp. The 510(k) number is K111247.

When did CRANIAL REMOLDING ORTHOSIS receive FDA 510(k) clearance?

CRANIAL REMOLDING ORTHOSIS received FDA 510(k) clearance on 2011-08-15, under 510(k) number K111247.

Who is the listed applicant for CRANIAL REMOLDING ORTHOSIS?

The FDA 510(k) record lists Orthotic Care Services, Llp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRANIAL REMOLDING ORTHOSIS?

The FDA product code for CRANIAL REMOLDING ORTHOSIS is MVA.

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Related Devices (Code: MVA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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